Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808525014911 Date of Approval: 28/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of birth preparedness savings on health facility delivery amongst women in self-help groups in Northeast Nigeria
Official scientific title A Cluster Randomized Trial of the impact of Birth Preparedness Savings Program on Health Facility Delivery in Gombe Northeast Nigeria
Brief summary describing the background and objectives of the trial Despite the global decline in number of women dying due to complications during pregnancy and childbirth, maternal deaths remain unacceptably high in sub-Saharan Africa. For example, Nigeria accounts for 19% of the global maternal deaths. Studies have shown skilled care during child birth as key in reducing maternal deaths with possible prevention of 65% of all maternal deaths. The absence of skilled care during childbirth is particularly worse in Northern Nigeria. Recent figures from Gombe state, in northeast Nigeria, showed 80% women with a live birth in the previous 12 months lacked skilled support. The State Accountability and Quality Improvement Project (SAQIP), which commenced in 2016 in Gombe, is implementing a community-based intervention aimed at increasing the utilization of skilled obstetric and newborn care services in primary health facilities. This study primarily aims to determine whether BPS increase health facility delivery amongst SAQIP’s mothers’ groups’ members who had a live birth in the previous 12 months (intervention) compared with similar members in mothers’ groups not offered BPS (control).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Behavioral Change
Anticipated trial start date 03/09/2018
Actual trial start date
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 2295
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Birth preparedness savings program PLUS WORTH Intervention Nine months On top of the WORTH intervention offered to all groups, the project will randomly offer some groups a birth preparedness savings (BPS) program. The Birth Preparedness Savings (BPS) program is aimed at further improving health facility delivery amongst pregnant members of the mothers’ groups (MGs). Under BPS, similar to World Health Organization’s approach, the project would particularly encourage and follow-up pregnant women in the groups to: plan for a desired birth attendant and birth-location; arrange for transportation to a health facility during labor and in case of any complications; identify support to look after the home and other children while the woman is away; identify compatible blood donors in case of complications; save extra funds weekly - besides what they normally save in the group - to cover costs associated with childbirth; and buy supplies and materials needed to bring to the facility during delivery and perinatal period25. The project will offer BPS to 135 of 540 existing MGs. The cash saved under BPS may be withdrawn by the pregnant member to offset catastrophic spending if obstetric emergencies are experienced in the antenatal period. Also, cash saved under BPS attracts interest over time. The BPS intervention will be facilitated by Village Health Workers(VHW). The VHWs are trained community member who provide preventative and curative services to mothers and newborns in communities they serve. They also double as facilitators of MGs routine activities. They will encourage the pregnant women in the groups to take-up and stay committed to BPS. The savings under BPS will be registered in the pregnant member’s BPS card and group’s savings register. Those who opt into BPS can liquidate savings at any time irrespective of their obstetric condition. It is theorized that the BPS will influence behavior of and lead to additional deliveries in health facilities amongst pregnant members of the groups, well above that occurring in the control groups. 135
Control Group WORTH Intervention Nine months The women iin the control groups are offered Pact’s unique WORTH intervention - an award-winning micro-banking program that empowers women to lift themselves and each other out of poverty - for 18 months. Every week, members of the groups receive obstetric and newborn health education, and lessons on how to read and write. Every two week, the groups conduct community banking sessions where all members are required to make small savings, and when group’s funds grow large enough, members may begin taking loans to start small businesses or expand an existing one. The members are also encouraged to save voluntarily into the group’s purse. This voluntary savings can be withdrawn at any time to meet life’s exigencies. The project provides no capital or seed money to these women. The groups only receive notebooks for recordkeeping and lock-boxes for storing their savings and ledgers. The groups are facilitated by two types of volunteers: (1) The maternal newborn and child health (MNCH)/ village health worker (VHW) volunteers who facilitate the groups’ health education sessions; and (2) the empowerment worker (EW) volunteers who facilitate the community banking sessions. These volunteers receive monthly stipend for transportation from SAQIP. The project theorizes that increased knowledge of obstetric and newborn emergencies, access to funds to start or expand an existing business, and literacy skill, will lead to improved household decision making around obstetric and newborn health, poverty status, literacy skills, willingness to utilize and pay for MNCH services. These changes will then lead to the actual utilization of MNCH services (in particular, health facility delivery) in hospitals by an increased number of pregnant women in these groups, which will then ultimately contribute to a reduction in maternal neonatal and child deaths. 135 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All 57 political wards and 2,295 members with a live birth in the last nine months will be eligible to participate in the study. Exclusion criteria New mothers’ groups formed during and/or after the baseline study; and new mother’s groups members that join the groups after the baseline study, will be excluded from the baseline and end line survey; and The cohort of pregnant women who delivered a live birth within three months of inception of BPS will be excluded from the study. It is assumed that pregnant women require at least three months of exposure to BPS to influence their place of delivery. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 Year(s) 59 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/08/2018 Gombe State Ministry of Health Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Along Ashaka Road, Opposite Gombe Federal Medical center, Gombe, Nigeria Gombe 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is health facility delivery amongst members with a live birth in the last 12 months. This will be measured via self-report questionnaires as a binary Yes/No categorical response during baseline and end line surveys. Baseline and endline
Secondary Outcome Poverty status, antenatal care visits and willingness to deliver in health facility will be measured via the same self-report questionnaire. Poverty status will be measured as a continuous variable using the 10-item questions adopted from the Grahmeen’s Foundation Poverty Probability Index (PPI) tool for Nigeria. The PPI is statistically-sound, yet simple to use: the answers to 10 questions about a household’s characteristics and asset ownership are scored to compute the likelihood that the household is living below the poverty line – or above by only a narrow margin. Antenatal care visit will also be measured as a continuous variable while willingness of pregnant members to deliver their babies in a health facility will be measured as categorical Yes/No response. Lastly, duration of exposure of each respondent to the different components of the BPS intervention will be measured as a continuous variable. Baseline and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pact West Africa 16. P.O.W Mafemi Crescent, Utako Abuja Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
State Accountability and Quality Improvement Project 3A, Yahaya Arabi Close, behind Government House, Gombe Gombe Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shobo Olukolade Road 212, House 1, Efab Global Estate Abuja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olukolade Shobo shoboolukolade@gmail.com +2348067812469 Road 212, House 1 Efab Global Estate
City Postal code Country Position/Affiliation
Abuja Nigeria Director Monitoring Evaluation Research and Learning Pact West Africa
Role Name Email Phone Street address
Public Enquiries Kolo Yakubu kyakubu@pactworld.org +2347039687127 3A, Yahaya Arabi Close, behind Government House, Gombe
City Postal code Country Position/Affiliation
Gombe Nigeria Project Director State Accountability and Quality Improvement Project
Role Name Email Phone Street address
Scientific Enquiries Olukolade Shobo shoboolukolade@gmail.com +2348067812469 Road 212, House 1 Efab Global Estate
City Postal code Country Position/Affiliation
Abuja Nigeria Director Monitoring Evaluation Research and Learning Pact West Africa
Role Name Email Phone Street address
Scientific Enquiries Amina AhmadShehu aahmadshehu@pactworld.org +2347015870416 16, P.O.W. Mafemi Crescent, Utako, Abuja, Nigeria
City Postal code Country Position/Affiliation
Abuja Nigeria Senior Technical Director Pact West Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information